evaluation of contour® usb bgms on glycaemic control in insulin-treated diabetic patients

Conditions: Diabetes Mellitus Type 2

Summary: the purpose of this study is to evaluate if the use of the contour next usb bgms system with autolog and trends features and integrated data management software (glucofacts ™ deluxe) enables behavioral changes that may lead to improvement in glycemic control, expressed as a reduction in hba1c as primary endpoint. patients will be randomized either to using contour next usb or contour. patients will be trained in using the devices and return every 3 months until month 9 after baseline.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * therapy with insulin only (ict) or ict in combination with metformin * hba1c at baseline \> 7.5% and \< 11% * patients at least 18 years of age * patients willing to complete all study visits and study procedures including: * testing their bg at least 3 times a day during the entire study. * using the paper logbook provided (control group) * using the auto log meal-marker + reminder feature in contour next usb regularly (test subjects only) * using the trends feature in contour next usb regularly (test subjects only) * uploading the contour next usb meter to personal computer (subject must have personal computer at home or access to a computer - see system requirements in appendix for technical details). * patients who are able to speak, read and understand german * patients who are currently performing self-testing of blood glucose at home routinely (at least 3 times per day) for 4 weeks or more * patients who are currently adjusting there insulin dosages themselves based on the self-testing of blood glucose at home * written informed consent at beginning of the study exclusion criteria: * patients who have been using contour next usb meter regularly during the previous 12 months * patients treated with oral antidiabetic drugs except for metformin; or diet alone * change of diabetes therapy within the last 3 months * change of hba1c level of more than ±0.5% within the last 3 months * patients who are using a continuous blood glucose measurement system regularly * patients with home health aides who assist with their bg testing and /or insulin adjustment * patients with macroalbuminuria * steroid therapy within the last 3 months. topic or inhalative use is no exclusion criterion when not used regularly (more than 5 times a week). * uncontrolled blood pressure ≥ 170/100 at screening * bmi \> 40 kg/m² * anemia according to who-definition (hemoglobin \< 13 g/100 ml \[male\] or \< 12 g/100 ml \[female\]) * creatinin \> 150 µmol/l and/or gfr \< 50 mmol/min/ 1.73m² (measured within the last 3 months before screening) * operation with inpatient stay planned during the study * current pregnancy or pregnancy planned during the study; or breastfeeding women. * women with childbearing potential who are not practicing an acceptable method of birth control. acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (iuds/iuss), oral, implantable or injectable contraceptives, sexual abstinence, double barrier method and vasectomized partner * alcohol or drug abuse within the last 3 months * patients with the following impairments which, in the opinion of the investigator, would seriously compromise the integrity of the study: * significant visual impairment * significant hearing impairment * cognitive disorder * significant unstable co-morbidity (with notable change within the past 3 months) * severe renal disease, disease with a strong impact on life expectancy * inability to have or use and computer * inability to use a meter correctly * any other condition as per investigator's discretion * current participation in another clinical study. participation in another trial within 6 weeks before screening. * employees of bayer vital diabetes care, the gwt or the university of dresden